Pred Forte 1 % Ophthalmic Suspension

Details

Generic Name: PREDNISOLONE ACETATE

Brand Name: PRED FORTE

Substance Name(s):
PREDNISOLONE ACETATE

WARNINGS

Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision.

Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.

Steroids should be used with caution in the presence of glaucoma.

Intraocular pressure should be checked frequently.

Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning.

Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.

Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.

PRED FORTE ® suspension contains sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.

The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.

Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

OVERDOSAGE

Overdosage will not ordinarily cause acute problems.

If accidentally ingested, drink fluids to dilute.

DESCRIPTION

PRED FORTE ® (prednisolone acetate ophthalmic suspension, USP) 1% is a sterile, topical anti-inflammatory agent for ophthalmic use.

Its chemical name is 11ß,17, 21-Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate and it has the following structure: Structural Formula: Each mL of PRED FORTE ® contains: Active: prednisolone acetate (microfine suspension) 1% Inactives: benzalkonium chloride as preservative; boric acid; edetate disodium; hypromellose; polysorbate 80; purified water; sodium bisulfite; sodium chloride; and sodium citrate.

The pH during its shelf life ranges from 5.0 – 6.0.

Structural Formula

HOW SUPPLIED

PRED FORTE ® (prednisolone acetate ophthalmic suspension, USP) 1% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows: 1 mL in 5 mL bottle – NDC 11980-180-01 5 mL in 10 mL bottle – NDC 11980-180-05 10 mL in 15 mL bottle – NDC 11980-180-10 15 mL in 15 mL bottle – NDC 11980-180-15 Storage: Store at up to 25°C (77°F).

Protect from freezing.

Store in an upright position.

All trademarks are the property of their respective owners.

Irvine, CA 92612 Made in the U.S.A.

71592US12 Allergan Logo

GERIATRIC USE

Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

INDICATIONS AND USAGE

PRED FORTE ® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

PEDIATRIC USE

Pediatric Use The safety and effectiveness in pediatric patients have been established.

Use in pediatric patients is supported by evidence from adequate and well-controlled studies of prednisolone acetate ophthalmic suspension in adults with additional data in pediatric patients.

PREGNANCY

Pregnancy Prednisolone has been shown to be teratogenic in mice when given in doses 1-10 times the human dose.

Dexamethasone, hydrocortisone, and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation.

A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice.

There are no adequate well-controlled studies in pregnant women.

Prednisolone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

NUSRING MOTHERS

Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

Because of the potential for serious adverse reactions in nursing infants from prednisolone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

INFORMATION FOR PATIENTS

Information for Patients Advise patients that if eye inflammation or pain persists longer than 48 hours or becomes aggravated, they should consult a physician.

Advise patients that to prevent eye injury or contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface.

The use of this bottle by more than one person may spread infection.

Keep bottle tightly closed when not in use.

Keep out of the reach of children.

Advise patients that PRED FORTE ® suspension contains benzalkonium chloride, which may be absorbed by soft contact lenses.

Contact lenses should be removed prior to application of PRED FORTE ® and may be reinserted 15 minutes following its administration.

DOSAGE AND ADMINISTRATION

Shake well before using.

Instill one to two drops into the conjunctival sac two to four times daily.

During the initial 24 to 48 hours, the dosing frequency may be increased if necessary.

Care should be taken not to discontinue therapy prematurely.

If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated (see PRECAUTIONS).